DMF (Drug Master File)
What Is a DMF (Drug Master File)? A Drug Master File (DMF) is a confidential regulatory submission made to authorities like the U.S. FDA. It contains detailed information about drug substances (APIs), excipients, packaging materials, and manufacturing processes. A DMF enables a manufacturer to protect proprietary information while supporting regulatory filings—such as INDs, ANDAs, NDAs, or CTDs—filed by a third party. DMFs are not approved or rejected by themselves; […]
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